MANAGE-AF Registry -MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)

NCT05978466 | Recruiting

• 1 other identifier: 2017-CSF-00100
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to learn more about the normal care of patients with a new or pre-existing diagnosis of atrial fibrillation (AF). These abnormal and irregular heartbeats place patients at increased risk of developing clots in their bloodstream that could potentially lead to stroke. Normal care is designed to help prevent this from happening and to lessen or eliminate the symptoms patients may have. There are many different types of AF as well as numerous ways in which a variety of patients are treated. The investigators are interested in gathering more information to better keep track of patient treatment patterns (trends) that may differ from physician to physician, hospital to hospital, medication to medication, patient to patient and if necessary, procedure to procedure.

Conditions

Atrial Fibrillation

Keywords

atrial arrhythmia; atrial fibrillation; stroke; bleeding; Left Atrial Appendage Occlusion

Outcome Measures

Primary Outcomes (3)

• Recurrence of Atrial fibrillation

  The natural progression of the condition will be assessed per medical record review

  From enrollment to 10- year study completion

• Number of participants who had thrombo-embolic event

  All strokes, transient ischemic and systemic thrombo-embolic events

  From enrollment to 10- year study completion

• Mortality

  All cause death will be noted

  From enrollment to 10- year study completion

Secondary Outcomes (4)

• Number of participants who have experienced bleeding

  From enrollment to 10- year study completion

• Number of patients who have had pro-arrhythmia events

  From enrollment to 10- year study completion

• Number of patients who have had patient adherence events

  From enrollment to 10- year study completion

• Treatment complication

  From enrollment to 10- year study completion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All subjects with the diagnosis of atrial fibrillation can be enrolled into the study regardless of sex, age or medical history

You may qualify if:

• Diagnosis of valvular or non valvular atrial fibrillation
• ECG documented atrial fibrillation A. 12 lead B. Rhythm strip C. Event monitor D. Holter Monitor E. Implantable loop recorder

You may not qualify if:

• Age below 18 years.
• Clinical evidence that death within 6 months is possible
• Inability to consent to the research or sign a consent form
• Inability to follow up at the research clinic at least annually for continuity of AF care and management

Sponsors & Collaborators

• CorVita Science Foundation: lead

Study Sites (1)

CorVita Science Foundation (NFP)

Chicago, Illinois, 60605, United States

RECRUITING

Related Links

• Research foundation's website

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Hemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Martin C Burke, DO

  Chief Scientific Officer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward M Burke

CONTACT

773-432-4888; eddie@corvitahealth.org

Martin C Burke, DO

CONTACT

773-432-4888; mburke@corvitahealth.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: August 7, 2023
• Study Start: December 22, 2017
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Intermittently over the next 10-15 years
• Access Criteria: Co-investigator who enrolls at least one patient

Locations

US (1)